FDA Medical Device Recalls (openFDA)
Bausch and Lomb, Incorporated: Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO. Crystalens Accommodating Posterior Chamber Intraocular Lens PMA No.: P030002. The Crystalens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia.
- Recall number
- Z-0445-2012
- Recalling firm
- Bausch and Lomb, Incorporated
- Product
- Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO. Crystalens Accommodating Posterior Chamber Intraocular Lens PMA No.: P030002. The Crystalens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia.
- Status
- Terminated
- Initiated
- 2011-11-14
- Posted
- 2012-01-11
- Terminated
- 2012-05-23
- Reason
- Bausch + Lomb voluntary initiated the recall due to a physician complaint of haze on the Crystalens AO which was visualized using an angled beam from a slit lamp during the post-operative examination.
- Root cause
- Nonconforming Material/Component
- Action
- Bausch + Lomb sent an "URGENT- MEDICAL DEVICE RECALL" letter dated November 14, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to remove the affected products from inventory and return the lenses to the firm. Additionally, a Recall Acknowledgement Form was attached to the letter for customers to complete and return with the affected products. Contact Bausch + Lomb at 949-521-7895 for questions regarding this recall..
- Quantity
- 62 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Serial No.: Expiration Date: 11-699865 to 11-699951 01/14/2016 11-699952 to 11-700027 01/14/2016
- 510(k) numbers
- not on file
- PMA numbers
- ["P030002"]
- Product code
- NAA
- Firm FEI
- 3004343135
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28